Effect of "Tiaoshen" acupuncture technique on mild depression and its underlying mechanism: A randomized controlled trial study protocol

Lu Bai; Wei Zou; Long Wang; Xueping Yu; Hongjun Lou; Xiaohong Dai; Wei Teng; Weiwei Yu; Mingyue Li; Hongtao Cao; Lei Zheng

doi:10.1016/j.heliyon.2024.e28889

Effect of "Tiaoshen" acupuncture technique on mild depression and its underlying mechanism: A randomized controlled trial study protocol

Heliyon. 2024 Mar 30;10(7):e28889. doi: 10.1016/j.heliyon.2024.e28889. eCollection 2024 Apr 15.

Authors

Lu Bai¹, Wei Zou^{2

3}, Long Wang⁴, Xueping Yu², Hongjun Lou⁴, Xiaohong Dai¹, Wei Teng¹, Weiwei Yu², Mingyue Li², Hongtao Cao², Lei Zheng²

Affiliations

¹ Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
² The third department of Acupuncture, the First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
³ Clinical Key Laboratory of Integrated Traditional Chinese and Western Medicine, Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
⁴ The first Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China.

Abstract

Background: Mild depression is not just a mental disease, but also a serious and long-term public health issue. It affects the quality of life of patients and can quickly develop into major depression. There are currently no effective drug treatments with high efficacy and few adverse reactions. Acupuncture may be an alternative treatment option. Preliminary experiments and practices have demonstrated that "Tiaoshen" acupuncture improves symptoms in patients who have depression, however the underlying data and method remain unclear at present.

Methods: This is a prospective, single-center, single-blind, randomized controlled trial. We plan to recruit 70 participants and randomly assign them to receive "Tiaoshen" acupuncture or traditional acupuncture at a ratio of 1:1. Then, all the participants will receive the appropriate acupuncture treatment for four weeks. The results of the Hamilton Depression Rating Scale (HDSR-24) will serve as the primary outcome, while the results of the Patient Health Questionnaire-9 (PHQ-9) and the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will serve as secondary outcomes. Evaluations will be conducted at baseline, 1, 2, and 4 weeks after treatment initiation, and 1 and 3 months after treatment completion. The safety of the intervention will be evaluated every week using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Treatment Emergent Symptoms Scale (TESS). Serum levels of oxidative stress markers 8-iso-prostaglandin F2α (8-iso-PGF2α), superoxide dismutase (SOD), uric acid (UA), and total bilirubin (TBIL) will be measured at baseline and the end of the treatment. We will conduct a statistical analysis of intention to treat (ITT) and conformance to protocol set (PPS) data.

Discussion: This research aims to provide high-quality evidence for the efficacy and safety of "Tiaoshen" acupuncture as a treatment for mild depression. In addition, the mechanism through which acupuncture heals mild depression will be investigated.

Keywords: Mild depression; Oxidative stress; Protocol; Randomized controlled trial “Tiaoshen” acupuncture.